FDA.reportPublic FDA data

Traxodent Gel Brush Tips

Primary DI
10818207025033
Brand
Traxodent Gel Brush Tips
Company
Vista Dental
Model
9007105
Published
2025-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KXRApplicator, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXRApplicator, ResinDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818207025033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081820702503310818207025033

GMDN Terms#

Term, Definition table
TermDefinition
Dental material injection cannula, single-useA rigid or semi-rigid luminal device (dental tip) intended to channel and dispense a dental material/solution [e.g., restorative amalgam, resin, etching solution (etchant), topical dental anaesthetic] from a dental syringe, or similar applicator, to a patient’s teeth, oral mucosa, or gums; it is not intended to penetrate tissue (it is not a needle), not dedicated to root canal irrigation, and may be used for dental applications outside the patients mouth. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
036623932
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10818207025170Fluorescent In Office Whitening Kit5042902026-07-20
00850194007763Zr-P Bottle905772026-06-04
00818207020840ZrP Syringe Kit905782021-01-29
10818207024920Endo Sealer Solvent3170332026-04-22
10818207024944Endo Sealer Solvent Sample317033-M2026-04-22
00850194007862Desensify12019-12-13
00850194007893Omni Etch Ceramic Etch and Silane12019-12-13
10818207024937EdgeUtopi BC Solvent 108182070249372025-03-17
10818207025071Endocator Starter Kit4077302025-11-07
10818207025088Endocator Swabs (20pk)4077312025-11-07
10818207025064ReminGelRGEL30002025-10-09
10818207020205Vista-Cal Standard Kit5026002018-07-31
10818207020878Velvet Etch 5033152021-05-13
30818207020872Velvet Etch 5033002021-05-13
00850194007787Purify+ Gel 5 Pack12019-12-13
00850194007794Purify+ Liquid 5 Pack12019-12-13
00850194007954Purify+ Gel Single Pack12019-12-13
00850194007961Purify+ Liquid Single Pack12019-12-13
20818207020202Vista-Cal Refill Kit5026012018-07-31
00850194007466RE-GEN Cleanser1907192016-06-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810194403293AiraAIRA, LLCKXR2026-08-25
00810194403309AiraAIRA, LLCKXR2026-08-25
00810194403323AiraAIRA, LLCKXR2026-08-25
00810194403330AiraAIRA, LLCKXR2026-08-25
00840456202555JMUJMU DENTAL, INCKXR2026-07-27
00840456202562JMUJMU DENTAL, INCKXR2026-07-27
00840456202579JMUJMU DENTAL, INCKXR2026-07-27
00840456202586JMUJMU DENTAL, INCKXR2026-07-27
00840456202593JMUJMU DENTAL, INCKXR2026-07-27
00840456218006JMUJMU DENTAL, INCKXR2026-07-27
00840456218013JMUJMU DENTAL, INCKXR2026-07-27
00840456218020JMUJMU DENTAL, INCKXR2026-07-27
00840456218037JMUJMU DENTAL, INCKXR2026-07-27
00840456202401JMUJMU DENTAL, INCKXR2026-07-08
00840456223222JMUJMU DENTAL, INCKXR2026-07-08
00840456223239JMUJMU DENTAL, INCKXR2026-07-08
D1257500B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257500G2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257500L2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257500Y2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257501B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257501G2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257501L2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257501Y2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257502T4Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257502W4Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257510B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257510G2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257510L2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257510Y2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21